Medtronic Announces Five-Year Clinical Data of Intrepid TMVR System Showing Over 80% of Patients Free from Mitral Regurgitation

Medtronic inAnnounced at the PCR London Valves 2025 conferenceTranscatheter Mitral Valve Replacement (TMVR)---Intrepid（Early Model) Five-year clinical data. The study showsIntrepidCan continuously eliminate mitral regurgitation (MR) and maintain long-term valve stability.

This study began in 2015, inEurope, Australia, and the United StatesThe 21 CentersIncluded 95 patients with symptomatic severe MR who were at high surgical risk.Intrepid（Early Model）Using the transapical delivery system.

Specific Research Data

• The average age of the patients was 74 years, of which 88.4% belonged to New York Heart Association (NYHA) functional class III or IV, and about 80% of the patients had secondary MR. The mortality and heart failure hospitalization rates continued to rise within the first six months. Considering the extremely high-risk characteristics of this population, this outcome was not surprising. The all-cause mortality rate was 31.9% at one year and reached 66.7% at five years; the heart failure hospitalization rates were 26% and 55.4% at one year and five years, respectively.

• Comparing clinical outcomes at two time points, cardiovascular mortality nearly doubled between one and five years (from 26.1% to 51.6%), but the Clinical Events Committee adjudicated that only about one-fifth of cardiovascular deaths were valve-related. At five years, 22.9% of patients had a myocardial infarction (zero cases in the first year), with the majority of these patients having a history of prior myocardial infarction.

• Intrepid can effectively reduce MR: 95% of patients had moderate to severe/severe MR at baseline.More than 80% of patients had no reflux or only trace reflux at the five-year mark, with the remaining patients all experiencing mild reflux.。

• The incidence rate of hemodynamic valve deterioration is1.4%, the median of the mean transvalvular pressure gradient was stable at3.6mmHg, at the five-year mark84.6% of patients achieved NYHA Class I/II heart function.。

PI Evaluation

"We know this is a very harsh in vivo environment, and the valve performed exceptionally well during this period. Further exploration of the transfemoral Intrepid through the APOLLO and APOLLO-EU studies will help determine the role of TMVR in treating this high-risk population."

---Michael Reardon  Houston Methodist Hospital

IntrepidWith the following characteristics:

• Simple positioning: brim design

• Simple Anchoring Without Capturing Flyers

• Minimized size, with less impact on surrounding structures

• No atrial prominence or contour

• Can be implanted with pacing leads.

• The gap between the two stent frames may allow for future pacemaker implantation.

Specifically Designed for TMVR and TTVR

• Allows multi-angle and multi-directional rotation to obtain various anatomical structures.

• Clearly visible under X-ray

• Maximum diameter 35Fr, suitable for severe casesSevereTricuspid RegurgitationPatient

IntrepidDelivery System Effect